CLASS II Device recall · Reported 9 Apr 2014 · FDA Enforcement Report

Spirit MB Bracket, UR Central +14T +5A.018 recalled by Ormco/Sybronendo

Ormco/Sybronendo is recalling Spirit MB Bracket, UR Central +14T +5A.018. The recall was initiated on 25 Mar 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesPart Number 494-0110, Lot Number 081351013.

Quantity recalled150 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1330-2014
FDA event ID: 67849
Recalling firm: Ormco/Sybronendo, Glendora, CA
Classification: Class II
Status: Terminated
Recall initiated: 25 Mar 2014
FDA classified: 3 Apr 2014
Reported: 9 Apr 2014
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Dental Devices

Timeline

25 Mar 2014	Recall initiated by company
3 Apr 2014	Classified by FDA	+9 days
9 Apr 2014	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Ormco Corporation initiated this recall of Spirit MB Brackets, Part Number 494-0110, Lot Number 081351013, because the ID dot, which designates the bracket as distal/gingival, is misplaced. The misidentification may lead an orthodontist to place the bracket on the wrong tooth, leading to movement 10 degrees in the wrong direction.

Product as listed by the FDA

Spirit MB Bracket, UR Central +14T +5A.018, Part Number 494-0110, Lot Number 081351013. Product Usage: An orthodontic bracket. Spirit MB Brackets are a fixed attachment on a tooth which holds an archwire during orthodontic treatment.

Where it was distributed

Internationally Distributed in the country of Japan.

Questions about this recall

Why was it recalled?

Which lots are affected?

Part Number 494-0110, Lot Number 081351013.

Where was it sold?

Internationally Distributed in the country of Japan.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Ormco/Sybronendo

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